The Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom (UK) has posted a medical device safety alert concerning Nit-Occlud Implantation Sheath, manufactured by PFM Medical AG. The affected devices are identified as follows:-
The manufacturer has received feedback from the outside European community that in individual cases the atraumatic tip (Soft Tip) of the Nit-Occlud Implantation Sheath detached during preparation and application under incorrect storage conditions (discoloration of the sterile packaging).
According to the manufacturer, the sheaths are being used to get access to the vessel system. Particles from the tip of the sheath therefore might embolize in the vessel system and as a result impede or stop the blood flow. Particles in the venous system could cause a pulmonary embolism or thrombosis. Embolizing particles in the arterial system could possibly result in infarction on all organ systems with tissue death (necrosis) and could result in heart attack and stroke. This can in the worst case lead to irreversible organ damage up to death
The manufacturer has not received any information so far that the products have quality problems when properly stored and used. However, due to the high potential risk of detachment, the manufacturer decided to recall the affected devices as a precaution in order to investigate them systematically.
For further details including the affected lot numbers, please refer to the MHRA website:
https://www.gov.uk/drug-device-alerts/field-safety-notice-13-to-17-november-2017
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 21 November 2017